Job Description

Role: Risk Management Quality Engineer

Location: Murrysville, PA (Hybrid)

Duration: 12 Months contract

Pay Range: $50.00- $59.00/hr W2 (without benefits and no paid vacations)

Description:

**3 days/week onsite required - Murrysville, PA**

Quality & Regulatory

Risk Management Quality Engineer, QA Engineer Risk Management

In this role, you have the opportunity to:

- Be a key developer in expanding our Quality & Regulatory Risk Management team for our Sleep and Respiratory Care organization.

- Create and implement new tools and methods to manage risk, contributing to the safety and efficacy of medical products that save lives and improve health.

You are responsible for:

- Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.

- Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.

- Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.

- Analyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.

- Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and procedures.

- Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.

- Create and continually improve procedures and work instructions to ensure reliable, repeatable results. Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.

You are a part of:

- An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that positively impact billions of people every year. Including you.

- Because you will find when you work that your professional and personal lives often intersect in unexpected and fulfilling ways.

- Our mission is to improve peoples lives through meaningful innovation.

- We want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues worldwide.

To succeed in this role, you should have the following skills and experience:

- BS in Engineering or a related field. MS preferred.

- 6+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.

- 2+ years experience with a MS or higher.

- Extensive hands on experience with the ISO 14971 standard.

- Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.

- Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.

- Demonstrated expertise in managing complex projects and implementing cultural change.

- Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.

- Experience working within a Quality Management System.

- Green Belt or Black Belt certification preferred.

- Excellent team work skills including influencing and building rapport with internal customers and stakeholders.,

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